Description and Brand Names

US Brand Name

Regranex

Descriptions

Becaplermin is used to treat skin ulcers, usually on the lower leg, in patients with type 2 diabetes mellitus. It works by stimulating the wound to heal. It is important to use other methods for good skin ulcer care when using becaplermin.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Gel/Jelly

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of becaplermin in children and teenagers younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of becaplermin in the elderly.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Cancer, any type—Use with caution. May make this condition worse.

Skin cancer or tumors at the site of the skin ulcer—Should not be used in patients with this condition.

Wounds that show exposed joints, tendons, ligaments, or bone—Use of becaplermin is not recommended because it is not known if it would work for these conditions.

Wounds that are closed manually by your doctor—Use of becaplermin is not recommended because these wounds require a sterile product.

Proper Use

To make using becaplermin as safe and reliable as possible, you should understand how and when to use this medicine and what effects may be expected.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Use this medicine only on your skin and only on the area prescribed by your doctor. Do not get it in your eyes, nose, mouth, or vagina. You should not use on any other rashes, sores, or cuts. If it does get on these areas, rinse it off right away.

It is important to prevent the tip of the tube from touching the skin ulcer or any other object. This will keep the medicine from being contaminated and a possible source of infection.

To use the gel:

Wash your hands before preparing your dose.

The proper amount of the gel to be measured depends on the size of the tube you are using and the size of the skin ulcer. You should expect the dose to change each week or every other week, depending on the rate your skin ulcer changes in size.

Measure the proper amount carefully onto a clean surface (e.g., wax paper). Close the tube tightly after each use. Then, transfer the medicine to your skin ulcer by using an applicator aid (e.g., a cotton swab, tongue depressor).

Spread the medicine on your skin ulcer as a thin (about 1/16 of an inch), even, continuous film.

After wetting a gauze pad with 0.9% Sodium Chloride Irrigation USP, apply it on top of your medicated skin ulcer.

After 12 hours, remove the medicine left on the skin ulcer with 0.9% Sodium Chloride Irrigation USP or water.

Keep the skin ulcer from becoming too dry. When changing the dressing, the existing bandage may need to be wetted with 0.9% Sodium Chloride Irrigation USP to help remove the bandage and prevent injury to the healing skin ulcer.

Wet a new gauze pad with 0.9% Sodium Chloride Irrigation USP. Apply it on top of your skin ulcer that no longer has the medicine on it and wait 12 hours before applying the medicine again. Therefore, the medicine is reapplied every 24 hours, with a change in the wound dressing in between applications.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage form (gel):

For skin ulcers caused by type 2 diabetes mellitus:

Adults and children 16 years of age and older—Apply to the affected area once a day and leave it on for 12 hours. The amount applied will change each week or every other week, depending on the changing size of the skin ulcer.

Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

This medicine should not be used after the expiration date. The date can be found at the bottom of the tube.

Precautions

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects. As your skin ulcer changes in size, your doctor may change your dose each week or every other week.

Becaplermin works best when used with other methods for good skin ulcer care, such as not bearing weight on the leg that has the skin ulcer. Your doctor will discuss these methods with you.

Discuss with your doctor whether you should continue the medicine if your skin ulcer is not reduced in size by 30% in 10 weeks or your skin ulcer does not improve after 20 weeks. If your skin ulcer does improve, your doctor may keep you on the medicine until the ulcer is completely healed.

It is important to use the proper amount and not to use more than prescribed. Using too much of this medicine may increase your risk of having cancer. Your doctor will decide if you should continue to use this medicine based on how well your skin ulcer has healed.

If burning, itching, redness, skin rash, swelling, or soreness at the application site occurs, stop using this medicine and check with your doctor right away.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Reddened skin near the skin ulcer

skin rash near the skin ulcer

Incidence not known

Burning sensation at the application site

unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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